Pharmacy Courses

Clinical Trial Feasibility Study

Clinical trial feasibility study is a process of evaluating the possibility of conducting a particular clinical program / trial in a particular geographical region with the overall objective of optimum project completion in terms of timelines, targets and cost.

Clinical Trial Feasibility Checklist

  • Where will patients come from (e.g., existing pool of patients, referral sources, advertising?)
  • How much time and resources will be required to recruit subjects? Will the sponsor be willing to provide funding for recruitment of subjects?
  • Does the sponsor need equipment and site qualification?
  • How many can be enrolled based on estimates and review?
  • What is the status of ongoing studies, which may compete for similar patients – when will these be ending?
  • What is the extent of involvement of the patient/caregiver? Will they require special transportation needs? Is there ample space in the waiting room/exam room to accommodate patients and family members?
  • Do you have adequate equipment, facilities and supplies?
  • What special equipment is required and does the Hospital have ready access to this equipment?
  • If not, will it have to be purchased or will the sponsor provide it?
  • What training is involved in learning how to operate the equipment?
  • Who will be responsible for maintaining equipment calibration logs?
  • Is technical support or service readily available in the event of equipment failure?
  • Will a local or central lab be used?
  • How and when will specimens need to be shipped? Will dry ice be available (if required)?
  • Do you have adequate staff, time and resources?
  • How much time will the study require of the investigator? CRC? Ancillary staff?
  • What are the current obligations of the study staff? Will new staff be required? Who will be responsible for hiring and training them?
  • Is the proposed budget adequate?
  • Is the sponsor prepared to provide additional training, equipment or funding to fill in any of the gaps you identify?
  • Is the protocol in final or draft form?
  • How willing is the sponsor to consider suggestions or modifications should you determine the protocol is not feasible as written?
  • What is duration of project?

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